Executive certification in Clinical Research, Pharmacovigilance & Clinical Data Management
Enhance your career in the pharmaceutical industry with LSCOPE’s 4-Month Executive Certification program which offers Comprehensive understanding into Clinical Research, Pharmacovigilance & Clinical Data Management. This program is designed for freshers and early stage working professionals seeking to gain in-depth knowledge and skills necessary to navigate the complex regulatory landscape.
The certifications are CPD accredited, ensuring that the curriculum meets high professional standards and contributes meaningfully to your career development. You will learn from a team of industry experts who bring extensive experience in pharmaceutical regulations, compliance, and market access, providing you with practical insights and real-world applications.
The program features Classroom learning, allowing you deep conceptual understanding of modules. This adaptability helps you utilise the conceptual learning method effectively. Throughout the course, you will explore essential topics mentioned in curriculum section.
In addition to technical knowledge, this program emphasizes the development of essential soft skills, including communication, teamwork, and problem-solving, which are vital for success in regulatory roles. You will also receive tailored support for job interviews, including mock interviews, resume workshops, and strategies to present yourself effectively in the competitive job market.
Upon completion of this certification, we can deepen their expertise in clinical research, pharmacovigilance, and clinical data management. This specialized certification program provides a comprehensive, practical understanding of the interconnected fields crucial for advancing pharmaceutical and healthcare innovations.
This program is mostly ideal for freshers & professionals into life science stream seeking to transition into regulatory affairs, and individuals aiming to enhance their expertise for career advancement or recent graduates looking to enter the pharmaceutical industry, professionals.
Why LSCOPE?
Globally Entitled Program
Get CPD accredited internationally recognized courses
Industry Experts
Get trained by specialized working professionals with hands on expertise
Globally Entitled Program
Acquire dual certifications in single program
Lifetime Placements
Assured dedicated placement assistance for lifetime validity
On Job Training
Hands on learning with on job training program in masters diploma
Tech Driven Learning
Enhance your upskilling journey with technology enabled learning
Program Benefits
- Cutting-Edge Research: Delve into the forefront of pharmaceutical research with our academic programs, exploring drug discovery, pharmacology, and novel methodologies. Foster your research acumen to contribute to the advancement of pharmaceutical science.
- Interdisciplinary Approach: Our courses encourage interdisciplinary collaboration, bridging the gap between pharmaceutical science and related fields, fostering a holistic understanding of healthcare innovation.
- Teaching Excellence: Learn from seasoned educators and researchers who are passionate about nurturing the next generation of pharmaceutical professionals. Our faculty brings a wealth of knowledge and experience to your learning journey.
- Advanced Industry Insights: Stay ahead in the competitive pharmaceutical industry by gaining knowledge of the latest trends, regulations, and market dynamics. Enhance your proficiency in areas like quality assurance, regulatory affairs, manufacturing, and more.
- Practical Application: Our courses provide practical, hands-on experience through case studies, real-world industry projects, and interactive workshops. Apply your learning immediately in your professional environment.
- Certification and Career Advancement: Acquire certifications that are recognized and valued within the industry. Use your newfound knowledge to open doors to career advancement opportunities.
- Build a robust network of peers, academics, and industry leaders. Engage in collaborative projects, knowledge-sharing, and thought-provoking discussions that will broaden your horizons and inspire new ideas.
- The pharmaceutical industry is a realm of constant innovation, where science meets healthcare, and where research can directly impact human well-being. Our Pharmaceutical Course Training program empowers you to become a driving force in this dynamic field, whether your journey is academic or industry-focused.
- By choosing our courses, you're investing in a future filled with possibilities. Whether you're stepping into the world of academia or seeking to sharpen your skills in the pharmaceutical industry, we're here to guide and support your professional growth. Join us in shaping the future of pharmaceuticals through education, collaboration, and dedication to excellence.
- A hybrid courses provides you with a choice depending on your budget, time and preference. You can attend the course in-person as a classroom training course. Or you can attend the course as a live online training course.
- Using video and microphone technology the classroom training session are recorded & delivered over the internet as a live or recorded online course. The price reflects your decision with the cost which you have paid can be redeemed through diverse facilities provided by institution.
- Our dedicated placement support department which works well to provide best
opportunities from the topmost pharmaceutical firms. - The career services team play a pivotal role, offering resume/CV workshops, mock interviews, and job placement assistance.
Curriculum
Clinical Research
- Overview of clinical research and its importance.
- Phases of clinical trials (Phase I-IV).
- Good Clinical Practice (GCP) guidelines.
- Regulatory authorities (FDA, EMA, CDSCO, etc.).
- Randomized controlled trials.
- Adaptive trial designs.
- Bioavailability and bioequivalence studies.
- Institutional Review Board (IRB) and Ethics Committee (EC).
- Informed consent process.
- Ethical guidelines (Declaration of Helsinki, Belmont Report).
- Investigational New Drug (IND) application.
- New Drug Application (NDA) and Abbreviated NDA (ANDA).
- Clinical trial protocols and dossier preparation.
- Site selection and initiation.
- Patient recruitment and retention.
- Monitoring visits and reporting.
- Statistical analysis in clinical trials.
- Clinical study report (CSR) preparation.
- Post-marketing surveillance studies.
Pharmacovigilance (PV)
- Importance of drug safety monitoring.
- History and development of pharmacovigilance.
- Roles of WHO, UMC, and national PV programs.
- Identifying adverse drug reactions (ADRs).
- Case processing: ICSR (Individual Case Safety Reports).
- Serious Adverse Events (SAEs) reporting timelines.
- Tools for signal detection (e.g., data mining, EudraVigilance).
- Risk-benefit analysis.
- Risk management plans (RMPs).
- PV requirements by FDA, EMA, MHRA, and CDSCO.
- International guidelines: ICH E2E, E2B.
- Coding systems: MedDRA and WHO-DD.
- Periodic safety update reports (PSURs).
- Aggregate reporting and DSURs.
- PV databases (Argus, ArisG, VigiFlow).
- Automation in PV (AI, RPA, machine learning).
Clinical Data Management (CDM)
- Role of CDM in clinical trials.
- Life cycle of clinical data.
- Data collection: CRF (Case Report Form) design.
- Database development and validation.
- Data cleaning and query resolution.
- Coding of medical terms: MedDRA, WHO-DD.
- Data standards: CDISC, SDTM, ADaM.
- Statistical software (SAS, SPSS, R).
- Use of EDC systems (e.g., Medidata Rave, Oracle Clinical).
- Data integrity principles.
- Audits and inspections in CDM.
- Regulatory standards (21 CFR Part 11, ICH-GCP).
Medical Writing and Documentation
- Importance and scope of medical writing.
- Skills required: technical, scientific, and language skills.
- Regulatory writing:
- Clinical Study Protocols (CSP).
- Investigator Brochures (IB).
- Clinical Study Reports (CSR).
- Common Technical Documents (CTD).
- Scientific writing:
- Manuscripts, research papers, and abstracts.
- Marketing and educational writing:
- Patient education materials.
- Slide decks and product monographs.
- AMA Manual of Style and ICMJE guidelines.
- Structure of scientific documents (IMRaD format).
- Ensuring clarity, consistency, and accuracy.
- Plagiarism checking and referencing tools (e.g., EndNote, Mendeley).
- Adherence to ethical and regulatory standards.
- Tools for automation and collaboration (e.g., Microsoft Word, LaTeX).
- Use of content management systems (CMS).
- Developing mock documents: CSR, IB, and abstracts.
- Review and editing exercises.
Who Can Enroll?
Candidates who are pursuing their degree into Life science Stream i.e. B. Pharm, BSc, BAMS, MBBS, MSc, M. Pharm, etc or Graduated Fresher and Working Professionals working or willing to work in Clinical Research Organizations (CROs), Pharmaceutical and Biotechnology Companies, Regulatory Bodies, Clinical Data Management Firms, Healthcare Consultants & looking to advance their career into Pharmaceutical Industry
Enrolment Process
Select the Course & Download the Brochure
Connect with Career Advisor
Registration & Fees Payment
LMS Activation
Skill Enhancement & Placement Assistance
Soft Skill Training:
- Presentation Skills.
- Email Etiquettes.
- LinkedIn Profile Building.
- Personality Development and Grooming.
Interview skills:
- Interview Do’s and Don’ts.
- Mock Interviews by industry experts.
- HR and Technical Interview Prep.
- One-on-One Interview mentorship Session.
